Trial record 1 of 2 for:    Combining Exercise and Cognitive Training to Improve Everyday Function
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Combining Exercise and Cognitive Training to Improve Everyday Function (EXACT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
St. Louis Jewish Community Center
St. Louis Naturally Occurring Retirement Community (NORC)
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01603784
First received: May 2, 2012
Last updated: May 18, 2012
Last verified: May 2012

May 2, 2012
May 18, 2012
March 2010
October 2012   (final data collection date for primary outcome measure)
  • Memory for Medical Information [ Time Frame: Change in memory task performance between baseline and 6 months ] [ Designated as safety issue: No ]
    This task measures the ability of the individual to learn and recall complex medical information, and the source of the information.
  • Cooking Breakfast task [ Time Frame: Change in task performance between baseline and 6 months ] [ Designated as safety issue: No ]
    Participants engage in a computerized laboratory simulation of a cooking task to assesses cognitive dimensions of planning, prospective memory, monitoring the progress of ongoing activity, anticipating potential problems, task switching, and task coordination.
  • Virtual Week task [ Time Frame: Change in task performance between baseline and 6 months ] [ Designated as safety issue: No ]
    Participants engage a computerized board game that simulates choices about, and recall of, daily and weekly activities.
Same as current
Complete list of historical versions of study NCT01603784 on ClinicalTrials.gov Archive Site
  • Activities of Daily Living--Yale Physical Activity Scale (YPAS) [ Time Frame: Baseline, Month 3, Month 6, Month 12 ] [ Designated as safety issue: No ]
    Questionnaire that objectively measures frequency and time spent per week performing common physical activities, which are used to caculate total weekly metabolic work (KCals).
  • Uniform Data Set (UDS) [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    A standardized interview to ascertain and assess demographic information, health status, cognitive status, medications, and functional status. The interview is conducted with the research participant and a collateral source historian.
  • Geriatric Depression Scale [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    A 15-item questionnaire to assess for symptoms of depression.
  • Late Life Function & Disability Index (LLFDI) [ Time Frame: Baseline, Month 6, Month 12 ] [ Designated as safety issue: No ]
    A standardized questionnaire to assess performance of activities of daily living (ADLs) and the level of difficulty experienced while performing each activity.
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline, Month 6, Month 12 ] [ Designated as safety issue: No ]
    Questionnaire to assess sleep quality and events in the prior month. Includes a section for roommate/bed partner response.
  • Objective Physical Performance Tests [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
    Physical Performance Test, Senior Fit Test, Dual Task Walking Speed. These tests objectively measure walking speed, muscle strength, balance, and coordination.
  • Prospective and Retrospective Memory Questionnaire (PMRQ) [ Time Frame: Baseline, Month 6, Month 12 ] [ Designated as safety issue: No ]
    Objective questionnaires to measure ability to learn and recall information.
  • Peak Aerobic Power [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
    The participant walks on a treadmill, with a progressively increased grade (level of incline)over a 8-15 minute period, with continuous measurements of expired oxygen and carbon dioxide. Information obtained is used to measure the total amount of work that the person performs during the test. The participant has continuous ECG monitoring during the test.
  • Cognitive assessment battery [ Time Frame: Baseline, Month 6, Month 12 ] [ Designated as safety issue: No ]
    Array of cognitive tasks to assess performance in a variety of areas. Includes Stroop (response time and attentional control), Trials A/B (sequencing), Crossing Off (motor control), Logical Memory (story recall), and Digit Symbol (corresponding symbols to digits).
Same as current
Not Provided
Not Provided
 
Combining Exercise and Cognitive Training to Improve Everyday Function
Combining Exercise and Cognitive Training to Improve Everyday Function

The purpose of this randomized, controlled, prospective study is to evaluate the benefits of combining aerobic exercise with cognitive training for optimizing cognitive function. The study will enroll 109 men and women, age 55-75 years who are in stable health and without contraindications to exercise or evidence of dementia or cognitive impairment. Individuals will be randomly assigned to one of four groups for six months: Aerobic Exercise and Health Education, Home Exercise and Cognitive Training, Aerobic Exercise and Cognitive Training, and Home Exercise and Health Education. Participants will undergo measurements of cognitive function, physical performance, and complete questionaires about daily activities, physical activity, and quality of life at baseline (pre-intervention), and at 6 and 12 months after baseline.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Effect of Exercise on Cognitive Function
  • Behavioral: Intensive Exercise
    Standardized aerobic training program that is individualized to each participant's fitness level, and supervised by a certified exercise specialist. Participants attend 3 training sessions per week for 6 months. The session begins with a 10-15 minute warm-up. Participants then exercise on a treadmill or stationary bike, followed by "cool-down" activities. Heart rate and rating of perceived exertion are used to evaluate exercise intensity. Participants begin at ~30 min/day 60-70% of HR max and/or an equivalent level of RPE, and progress to 45-50 minutes at 75-85% for HR max.
  • Behavioral: Home Exercise
    Exercise program consisting of stretching, range of motion, and simple yoga exercises designed to improve flexibility. Each participant has a 60-minute sessions with an exercise trainer to teach them how to perform the exercises correctly. They are also given diagrams illustrating the exercises, along with written instructions. They are instructed to perform these exercises at home at least 3 times per week for 30 - 45 minutes. They also go to the recreational center monthly to meet with an exercise trainer to ensure that they are doing the exercises correctly. Participants record their exercise activities on a calendar for the 6 months.
  • Behavioral: Cognitive Training
    Computer-based training that is is administered 3 days per week for 8 weeks during months 5 and 6. The training program focuses on 3 types of cognitive processes: task coordination, prospective memory, and retrospective memory retrieval. One day of the week is devoted to each of the three cognitive processes. Some training sessions include a homework assignment for application and practice of the target cognitive processes in everyday activities.
  • Behavioral: Health Education
    Weekly educational sessions are administered during months 5 and 6, conducted at the recreational center by research staff. Sessions last 1 hour, and cover health and other topics unrelated to exercise or cognition, such as nutrition, hearing loss, stroke, and saving energy in one's home. At the completion of each session, participants are given a "homework" assignment.
  • Experimental: Combined
    Aerobic Exercise + Cognitive Training
    Interventions:
    • Behavioral: Intensive Exercise
    • Behavioral: Cognitive Training
  • Experimental: Exercise
    Aerobic Exercise + Health Education
    Interventions:
    • Behavioral: Intensive Exercise
    • Behavioral: Health Education
  • Experimental: Cognitive
    Home Exercise + Cognitive Training
    Interventions:
    • Behavioral: Home Exercise
    • Behavioral: Cognitive Training
  • Experimental: Control
    Home Exercise + Health Education
    Interventions:
    • Behavioral: Home Exercise
    • Behavioral: Health Education
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
109
May 2013
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age 55-75 years (inclusive)
  • English-speaking
  • sufficient visual and auditory perception to complete testing
  • available informant (someone who knows the individual well)
  • Clinical Dementia Rating of 0 (non-demented per the screening assessment).

Exclusion Criteria:

  • participation in a regular exercise program in last 6 months
  • participation in a cognitive training program in last 6 months
  • inability to walk on a treadmill or ride an exercise bike
  • less than a 10th grade education
  • mild cognitive impairment or dementia
  • cigarette smoking within the previous year
  • history of alcohol or substance abuse
  • BMI greater than 35
  • insulin-dependent diabetes
  • major and/or unstable medical, neurological, or psychiatric disorder, including:

    • active congestive heart failure
    • unstable angina
    • effort angina
    • nocturnal angina
    • MI within previous 6 months
    • ECG evidence of serious arrhythmias and/or acute myocardial ischemia reflected by ST-segment depression of 0.3 mm
    • resting blood pressure above 170 systolic or 100 diastolic
    • chronic infections
    • advanced arthritis
    • contractures or weakness due to CVA that would prevent adequate performance of the exercises.
    • disabling stroke
    • late stage renal or liver disease
    • major affective disorder with active symptoms
Both
55 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01603784
201102416, 1R01AG034581-01
Yes
Washington University School of Medicine
Washington University School of Medicine
  • St. Louis Jewish Community Center
  • St. Louis Naturally Occurring Retirement Community (NORC)
Principal Investigator: Ellen Binder, MD Washington University School of Medicine
Washington University School of Medicine
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP